Even over-the-counter (OTC) medications, like NSAIDs, have been linked to serious and even fatal health events (see BMJ Research: NSAIDs & The Risk Of Heart Failure), and many common OTC cold remedies are no long considered safe for children (see Inappropriate Use Of OTC Medicines In Children).
While most drugs are safe when taken as directed, it is also true that there is no such thing as drug that is 100% safe for 100% of the population 100% of the time. As with all medicines, there is always a trade off; balancing the risk vs. reward.
So much so that I don't think twice about getting a flu shot every year - not only to prevent the flu - but to also reduce my odds of having a heart attack or a stroke (see AHA: Study Shows Flu Shots Reduce Deaths From Heart Failure and Flu Vaccine May Lower Stroke Risk in Elderly ICU Patients).Compared to other pharmaceutical products, however, vaccines have an excellent safety profile.
But I confess I'm concerned over our `warp speed' approach to creating a COVID-19 vaccine. And I'm even more worried when nations (like Russia) decide to eschew rigorous phase III testing before rolling out an experimental vaccine to the general public.
I've previously expressed my concerns over the vaccine hype and `over-promising' by governments (see `Forward Looking' & `Aspirational' Vaccine Press Releases), particularly given the dismal track record in creating other coronavirus vaccines (SARS-CoV, MERS-CoV, hCoV).
And recent studies have called into question the ability of a SARS-CoV-2 vaccine to elicit a robust and long-lasting immune response in humans (see Kings College: Longitudinal Evaluation & Decline of Antibody Responses in SARS-CoV-2 infection).
While I suspect that given enough time and money, a safe and (reasonably) effective vaccine can be developed, I've also seen first hand how quickly a `rushed' pandemic vaccine campaign can go off the rails.
So with your permission, a look back to 44 years ago, and at the very minor part I played in a Swine Flu Vaccine debacle that helped to set back public confidence in flu shots for decades to come.
In the summer of 1976, when I was an impossibly young freshly-minted paramedic (see photo above), public health authorities were preparing for the feared return of a 1918-style H1N1 pandemic after a handful of soldiers at Fort Dix, NJ had fallen ill with a novel flu virus the previous winter.
H1N1 had last circulated in 1957, and we'd seen two (far milder) pandemics (H2N2 in 1957 and H3N2 in 1968) in the previous 20 years. Because of its similarity to the 1918 pandemic virus, public health authorities were preparing for the worst.
The decision to create an emergency vaccine, and produce it in quantity, was made in the spring. Their ambitious goal was to vaccinate 220 million Americans before the next flu season began.
At the time I was 22, working for a county EMS on the west coast of Florida, and that summer was loaned out to the county health department to assist in their public awareness program (and later, vaccinations).
While I wasn't particularly knowledgeable about pandemics, I'd already done the `rubber chicken circuit' as the county's 1st paramedic, I didn't mind public speaking . . . and most importantly, I was willing to do it on my days off for free.
So that summer I was booked at every local trailer park and community clubhouse, along with the Rotary, Kiwanis, Moose, Elks - and even high schools - to speak on Pandemic Flu and the importance of vaccination that fall.
I also served on county's Civil Defense planning commission, was the in-service training instructor for our County EMS, and that fall, would give thousands flu shots for the health department. It was a very busy summer.
Not surprisingly, many of my patients had been teenagers or even young adults in 1918, and I had an opportunity to talk to some of them about the experience. Their vivid recollections did little to comfort me that summer.
That generation is all but gone today, but their stories linger on (see HHS Documentary We Heard The Bells).
It was an election year and the bi-centennial. Richard Nixon had appointed Gerald Ford President Vice President after Sprio Agnew resigned in 1973, and he ascended to the presidency when Nixon resigned a year later. (Corrected Hx) Ford badly needed a public mandate. He was an unelected President, and his administration got off to a bumpy start.
Today, some critics believe that Ford used the Swine Flu threat for political reasons. Possible, I suppose, but I honestly believe that the administration’s fears of a pandemic were legitimate.
Throughout the summer, we all waited for the vaccine to arrive. Waited, planned, and worried. While summer is rarely a time of seasonal flu, we all knew that a pandemic strain respected no season.
By Late September, the vaccine was delivered nationwide.
Discussions were held again, at the highest level. The vaccine was ready, but no new cases had been reported. Was it the right thing to do, to inoculate the whole country? Some health officials argued against it.
But most agreed, to wait could invite disaster. It was expected it could take months to vaccinate everyone; better to start before the first wave arrived.
So in early October, we got the go ahead. We set up vaccination stations in schools, shopping malls, and community centers. Back then; we used the pneumo-jet system, instead of needles. Today, that has fallen out of favor. Too much chance, in this age of AIDS and Hepatitis, of spreading other diseases. And mishandled, the high pressure injection could rip the skin.
On one occasion, our pneumo-jet system failed, and we had to quit early in the morning. Sorry folks, come back tomorrow.
Then the first reports of suspicious deaths, and a strange form of paralysis made the paper.
But the seeds of mistrust had been sown. Fewer and fewer people showed up to get their shot.
The vaccine was blamed for a number of deaths, and cases of Guillain-Barre Syndrome (a form of paralysis). The fear of the vaccine was exacerbated by newspaper speculation. But the truth is, we were vaccinating a lot of elderly people, and many of their deaths, while attributed to the vaccine in the press, were likely due to other causes.
Overall, the incidence of Guillain-Barre Syndrome was somewhere around 10 out of a million vaccinations. Or five times higher than the background level of this disease.
By early December, we’d managed to vaccinate over 40 million people nationwide, but still far short of our goal. And this was a monumental national effort, and considered a national priority.
But surprisingly, no cases of Swine Flu had been reported anywhere in the world. Faced with bad publicity, and no pandemic threat, the decision was made to halt the vaccination program. We went on to see an relatively lackluster flu season.
Ironically, a year later we would be slammed by an H1N1 virus - the first in 20 years - which sparked a relatively mild pseudo-pandemic, primarily affecting those under the age of 20.Dubbed the `Russian Flu', it has been long speculated that it escaped from either a Chinese or Russian lab freezer, as it was incredibly similar to a strain from the 1950s. Unlike in previous `pandemics', H1N1 did not supplant the then current influenza A strain (H3N2), and continued to co-circulate with it until 2009.
Of course, had a ferocious 1918-style pandemic hit, the incidence of side effects would have been considered acceptable losses.
We learned a lot about mass inoculations, and the difficulties of pulling off that sort of thing. Lessons that to this day worry me.
For a remembrance from the perspective of CDC's director at the time, you may wish to read :
Reflections on the 1976 Swine Flu Vaccination Program
David J. Sencer*and J. Donald Millar†
- Good intentions don't necessarily produce good results.
- The logistics of delivering an emergency vaccine to hundreds of millions of people (who may require 2 doses, 28 days apart) - even months before an outbreak has begun - is a formidable task.
- Delivering a vaccine in the midst of a raging pandemic - hampered by social distancing and fears of contagion - will be ten times harder.
- The newspaper hype on the real (and imagined) dangers of the 1976 vaccine can't begin to hold a candle to the social media spin machine of today. Every death, every adverse reaction - even those that can only be loosely inked to the COVID vaccine - will become a daily cause célèbre on every social media platform.
- Based on the hype and over-assurance of our government - and by others around the world - the public's expectations of receiving (en masse) a safe and reasonably (50%-70%) effective COVID vaccine `sometime' the first half of 2021 sets a very high bar for `success'.
While I remain hopeful a safe and effective SARS-COV-2 vaccine can eventually be developed and deployed, an inordinate number of things will have to go perfectly in order to meet public's current expectations.
There a lot of potential points of failure in the development of any new vaccine, and given how well things have gone over the first 7 months of this pandemic, a perfect run doesn't seem likely.
If we don't begin to ground the public's expectations in reality - on both the effectiveness and likely availability of a COVID-19 vaccine in 2021 - even a limited, reasonably successful roll out of the vaccine will be viewed as a failure.
If things go perfectly, great. We'll all celebrate. But it is always better to under-promise and over-deliver, than the other way around.
